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Descriptor English: Diagnostic Test Approval
Descriptor Spanish: Aprobación de Pruebas de Diagnóstico
Descriptor autorización de pruebas diagnósticas
Scope note: Proceso por el cual se obtiene la aprobación por un organismo regulador gubernamental de REACTIVOS DIAGNÓSTICOS Y EQUIPOS DE PRUEBAS. Incluye cualquier prueba preclínica o clínica, revisión, presentación y evaluación de las solicitudes y los resultados de las pruebas y la vigilancia después de la introducción en el mercado.
Descriptor Portuguese: Aprovação de Teste para Diagnóstico
Descriptor French: Agrément de test diagnostique
Entry term(s): Approval, Diagnostic Test
Approvals, Diagnostic Test
Diagnostic Test Approvals
In Vitro Diagnostic Device Approval
Tree number(s): E05.337.275.500
N06.850.210.275.500
RDF Unique Identifier: https://id.nlm.nih.gov/mesh/D057069
Scope note: The process of gaining approval by a government regulatory agency for DIAGNOSTIC REAGENTS AND TEST KITS. This includes any required preclinical or clinical testing, review, submission, and evaluation of the applications and test results, and post-marketing surveillance.
Allowable Qualifiers: EC economics
HI history
LJ legislation & jurisprudence
ST standards
TD trends
Public MeSH Note: 2010
History Note: 2010
DeCS ID: 53721
Unique ID: D057069
Documents indexed in the Virtual Health Library (VHL): Click here to access the VHL documents
Date Established: 2010/01/01
Date of Entry: 2009/07/06
Diagnostic Test Approval - Preferred
Concept UI M0534190
Scope note The process of gaining approval by a government regulatory agency for DIAGNOSTIC REAGENTS AND TEST KITS. This includes any required preclinical or clinical testing, review, submission, and evaluation of the applications and test results, and post-marketing surveillance.
Preferred term Diagnostic Test Approval
Entry term(s) Approval, Diagnostic Test
Approvals, Diagnostic Test
Diagnostic Test Approvals
In Vitro Diagnostic Device Approval - Narrower
Concept UI M0536250
Preferred term In Vitro Diagnostic Device Approval



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